This is a Phase II, single-arm, single-center study evaluating Chidamide combined with a PD-L1 inhibitor, carboplatin, and etoposide as first-line therapy in extensive-stage small-cell lung cancer (ES-SCLC) patients. The primary objective is to assess Progression-Free Survival (PFS) per RECIST v1.1. Secondary objectives include Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (OS), and safety. Approximately 36 participants will receive induction therapy (Chidamide + chemotherapy + PD-L1 inhibitor) for 4 cycles, followed by Chidamide maintenance until progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Induction Phase: Chidamide 15 mg orally on days 1, 4, 8, 11, 15, and 18 of each 21-day cycle for 4 cycles.PD-L1 inhibitor, carboplatin, and etoposide are administered per their respective prescribing information. Maintenance Phase: Chidamide 20 mg orally twice weekly (at least 3 days apart) until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.PD-L1 inhibitor is administered per their respective prescribing information.
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGProgression-Free Survival (PFS) per RECIST v1.1 as assessed by the investigator.
Time frame: baseline up to approximately 24 months
Objective Response Rate (ORR) per RECIST v1.1.
Time frame: baseline up to approximately 24 months
Disease Control Rate (DCR) per RECIST v1.1.
Time frame: baseline up to approximately 24 months
Duration of Response (DOR) per RECIST v1.1
Time frame: baseline up to approximately 24 months
Overall Survival (OS)
Time frame: baseline up to approximately 24 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: baseline up to approximately 24 months
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